2023-11354: Medication Guides: Patient Medication Information

Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its human prescription drug product labeling regulations for Medication Guides (FDA-approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and content that would be submitted to FDA for approval. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

The agency’s own summary, as published.

What this changes

Amends 5 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 201 Labeling
• 21 CFR 208 Medication Guides for Prescription Drug Products
• 21 CFR 314 Applications for FDA Approval to Market a New Drug
• 21 CFR 606 Current Good Manufacturing Practice for Blood and Blood Components
• 21 CFR 610 General Biological Products Standards